FDA Adverse Event Malfunction Summary report: N

BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM

MDR report key: 7357486 · Received March 21, 2018

Report

Report Number: 9610847-2018-00064
Event Type: Malfunction
Date Received: March 21, 2018
Date of Event: February 28, 2018
Report Date: March 27, 2018
Manufacturer: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
Product Code: FOZ
UDI-DI: 30382903835912
PMA / PMN Number: K173354
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THE INITIAL MDR REPORTED THE PRODUCT INCORRECTLY. THE CORRECT BD PRODUCT IS BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM.

Additional Manufacturer Narrative · 1

A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative · 1

SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS OCCURRENCE. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF REPORTED LOT NUMBER 7143608. WE COULD NOT CONFIRM A SPECIFIC ROOT CAUSE FOR THIS ISSUE SINCE NO SAMPLE OR PHOTO WAS SENT FOR EVALUATION, WE COULD NOT DETERMINE IF IT WAS USER OR MANUFACTURING RELATED. NO CORRECTIVE ACTION WAS INITIATED SINCE THIS ISSUE COULD NOT BE CONFIRMED AS A MANUFACTURING RELATED ISSUE.

Description of Event or Problem · 1

IT WAS REPORTED THAT A HISSING SOUND WAS HEARD AFTER UNCLAMPING A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
199590	BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM	INTRAVASCULAR CATHETER	FOZ	BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.		7143608	30382903835912

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other